Transventricular implant tools and devices

ABSTRACT

A method and implantation tools for placing a transventricular splint including a tension member. The method includes gaining access to the patient&#39;s hearts and identifying entry or exit points for the tension member, marking those locations and delivering the tension member. Anchors for the tension member are also delivered. The length of the tensions member is measured and the walls of the heart drawn together. The pads are secured to the tension member and the tension member is trimmed to length. The pads are secured to the heart surface.

RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 11/044,502, filed Jan. 28, 2005 now abandoned, which is acontinuation of U.S. application Ser. No. 10/191,379, filed Jul. 9, 2002now U.S. Pat. No. 7,722,523, which is a continuation of U.S. applicationSer. No. 09/864,320, filed May 25, 2001, now U.S. Pat. No. 6,746,471,which is a continuation of U.S. application Ser. No. 09/123,977, filedJul. 29, 1998, now U.S. Pat. No. 6,260,552, the entire disclosures ofwhich are incorporated herein by reference. This application is relatedto U.S. application Ser. No. 09/124,321, filed Jul. 29, 1998 andentitled “Stress Reduction Apparatus and Method” and U.S. applicationSer. No. 09/124,286, filed Jul. 29, 1998 and entitled “Heart WallTension Reduction Apparatus and Method”, both of which are incorporatedherein by reference.

FIELD OF THE INVENTION

The present invention pertains to the field of apparatus for treatmentof a failing heart. In particular, the apparatus of the presentinvention is directed toward implanting a device for reducing wallstress in the failing heart.

BACKGROUND OF THE INVENTION

The syndrome of heart failure is a common course for the progression ofmany forms of heart disease. Heart failure may be considered to be thecondition in which an abnormality of cardiac function is responsible forthe inability of the heart to pump blood at a rate commensurate with therequirements of the metabolizing tissues, or can do so only at anabnormally elevated filling pressure. There are many specific diseaseprocesses that can lead to heart failure with a resulting difference inpathophysiology of the failing heart, such as the dilatation of the leftventricular chamber. Etiologies that can lead to this form of failureinclude idiopathic cardiomyopathy, viral cardiomyopathy, and ischemiccardiomyopathy.

The process of ventricular dilatation is generally the result of chronicvolume overload or specific damage to the myocardium. In a normal heartthat is exposed to long term increased cardiac output requirements, forexample, that of an athlete, there is an adaptive process of ventriculardilation and myocyte hypertrophy. In this way, the heart fullycompensates for the increased cardiac output requirements. With damageto the myocardium or chronic volume overload, however, there areincreased requirements put on the contracting myocardium to such a levelthat this compensated state is never achieved and the heart continues todilate.

The basic problem with a large dilated left ventricle is that there is asignificant increase in wall tension and/or stress both wring diastolicfilling and during systolic contraction. In a normal heart, theadaptation of muscle hypertrophy (thickening) and ventricular dilatationmaintain a fairly constant wall tension for systolic contraction.However, in a failing heart, the ongoing dilatation is greater than thehypertrophy and the result is a rising wall tension requirement forsystolic contraction. This is felt to be an ongoing insult to the musclemyocyte resulting in further muscle damage. The increase in wall stressis also true for diastolic filling. Additionally, because of the lack ofcardiac output, there is generally a rise in ventricular fillingpressure from several physiologic mechanisms. Moreover, in diastolethere is both a diameter increase and a pressure increase over normal,both contributing to higher wall stress levels. The increase indiastolic wall stress is felt to be the primary contributor to ongoingdilatation of the chamber.

Prior art treatments for heart failure fall into three generallycategories. The first being pharmacological, for example, diuretics. Thesecond being assist systems, for example, pumps. Finally, surgicaltreatments have been experimented with, which are described in moredetail below.

With respect to pharmacological treatments, diuretics have been used toreduce the workload of the heart by reducing blood volume and preload.Clinically, preload is defined in several ways including leftventricular end diastolic pressure (LVEDP), or left ventricular enddiastolic volume (LVEDV). Physiologically, the preferred definition isthe length of stretch of the sarcomere at end diastole. Diuretics reduceextra cellular fluid which builds in congestive heart failure patientsincreasing preload conditions. Nitrates, arteriolar vasodilators,angiotensin converting enzyme inhibitors have been used to treat heartfailure through the reduction of cardiac workload through the reductionof afterload. Afterload may be defined as the tension or stress requiredin the wall of the ventricle during ejection. Inotropes such as digoxinare cardiac glycosides and function to increase cardiac output byincreasing the force and speed of cardiac muscle contraction. These drugtherapies offer some beneficial effects but do not stop the progressionof the disease.

Assist devices include, for example, mechanical pumps. Mechanical pumpsreduce the load on the heart by performing all or part of the pumpingfunction normally done by the heart. Currently, mechanical pumps areused to sustain the patient while a donor heart for transplantationbecomes available for the patient.

There are at least three surgical procedures for treatment of heartfailure: 1) heart transplant; 2) dynamic cardiomyoplasty; and 3) theBatista partial left ventriculectomy. Heart transplantation has seriouslimitations including restricted availability of organs and adverseeffects of immunosuppressive therapies required following hearttransplantation. Cardiomyoplasty includes wrapping the heart withskeletal muscle and electrically stimulating the muscle to contractsynchronously with the heart in order to help the pumping function ofthe heart. The Batista partial left ventriculectomy includes surgicallyremodeling the left ventricle by removing a segment of the muscularwall. This procedure reduces the diameter of the dilated heart, which inturn reduces the loading of the heart. However, this extremely invasiveprocedure reduces muscle mass of the heart.

SUMMARY OF THE INVENTION

The present invention relates to methods and devices for placing atransventricular splint to reduce mechanical heart wall muscle stress.Heart wall muscle stress is a stimulus for the initiation andprogressive enlargement of the left ventricle in heart failure. Althoughthe primary focus of the methods of the present invention is heartfailure and thus placement of a splint on the left ventricle, themethods and devices of the present invention could be used to place asplint or reduce stress in the heart's other chambers.

The transventricular splints placed by the tools and methods of thepresent invention can reduce heart wall stress throughout the cardiaccycle including end diastole and end systole. Alternately, they can beused to reduce wall stress during the portions of the cardiac cycle notincluding end systole. The splints which operate throughout the cardiaccycle are referred to herein as “full cycle splints”. Those splintswhich do not operate to reduce wall stress during end systole arereferred to as “restrictive devices” or, more specifically, “restrictivesplints”. Splints reduce left ventricle wall stress by altering thegeometric shape of the left ventricle.

In the preferred embodiment of the present invention, tools are providedto interconnect oppositely disposed ventricular walls by atransventricular splint, including a tension member and anchors disposedon opposite ends of the tension member. First access is gained to theheart either by opening a patient's chest or less invasively by port ortrocar. The points on the ventricular walls to be interconnected by thesplint are then identified. The locations are preferably marked. Thetension member is then placed to extend between the marked locations.The distance between the marked location is preferably measured. Thewall of the ventricles are drawn toward each other. The anchors aresecured to the tension member. The tension member is trimmed or cut tosize in view of the relative spacing of the anchors. The anchors arethen secured to the heart.

In this manner, portions of the walls of the ventricle are fixed in adrawn position reducing the radius of curvature of the majority of theventricle and thereby reducing the tension within the ventricle wall.

BRIEF DESCRIPTION OF THE FIGURES

Referring now to the drawings wherein like reference numerals refer tolike elements throughout the several views, FIG. 1 is a cross sectionalview of the left ventricle including a transventricular splint;

FIG. 1A is a generally horizontal cross sectional view of a leftventricle including the transventricular splint of FIG. 1;

FIG. 2 is an exterior view of the heart of FIG. 1 and anchor pad of thetransventricular splint;

FIG. 3 is a location device with bars;

FIG. 4 is an exterior view of a heart including the location device ofFIG. 3;

FIG. 5 is a hand including a finger echo locator device;

FIG. 6 is a top view of the echo locator device of FIG. 5;

FIG. 7 is a side view of the echo locator device of FIG. 6;

FIG. 8 is a side view of a balloon locator device;

FIG. 9 is a side view of balloon locator device with balloon inflated;

FIG. 10 is a view of a mechanical locator disposed within and outside ofa left ventricle;

FIG. 11 is a clamp locator device;

FIG. 12 is a view of the device of FIG. 11 disposed on a left ventricle;

FIG. 13 is a view of an alignment tool;

FIG. 14 is a view of an alternative alignment tool;

FIG. 15 is yet another alternative alignment tool;

FIG. 15A is a detail of the alignment tool of FIG. 15;

FIG. 16 is a cross sectional view of an alignment tool pad withstabilizing apparatus;

FIG. 17 is a side view of an alternate embodiment of an alignment devicepad with stabilizing apparatus;

FIG. 18 is a perspective view of an alignment device pad;

FIG. 19 is a perspective view of an alternate embodiment of an alignmentdevice pad;

FIG. 20 is yet another alternate embodiment of an alignment devicereceiving pad;

FIG. 21 is a perspective view of an alignment device guide tube;

FIG. 22 is a side view of a splint delivery guide;

FIG. 23 is an alternate embodiment of a splint delivery guide;

FIG. 24 is an alternate embodiment of a stylet;

FIG. 25 is yet another alternate embodiment of a stylet including aretractable sheath in a retracted position;

FIG. 26 is a view of the stylet of FIG. 25 showing the sheath coveringthe tip of the stylet;

FIG. 27 is a yet another alternate embodiment of a stylet including aballoon disposed proximate the tip;

FIG. 28 is a view of the stylet of FIG. 27 wherein the balloon isinflated to cover the tip of the stylet;

FIG. 29 is a view of yet another alternate embodiment of a splintdelivery guide including an optical fiber;

FIG. 30 is a view of the tip of the guide of FIG. 29;

FIG. 31 is an alternate embodiment of a guide including an opticalfiber;

FIG. 32 is a view of yet another alternate embodiment of a guideincluding an optical fiber;

FIG. 33 is a perspective view of a guide clamp;

FIG. 34 is a perspective view of a wire guide clamp connected to adelivery tube;

FIG. 35 is a view of an alternate embodiment of a splint and deliverydevice;

FIG. 36 is a view of yet another alternate embodiment of a splint anddelivery device;

FIG. 37 is a view of the device of FIG. 36 connected in a leftventricle;

FIG. 38 is a tension member delivery catheter shown in a left ventricle;

FIG. 39 is a view of a hypotube placed in the left ventricle using thecatheter of FIG. 38;

FIG. 40 is a view of the hypotube of FIG. 39 being removed from the leftventricle;

FIG. 41 is a view of two guide members placed in the left ventricleusing the catheter of FIG. 38;

FIG. 42 is a view of a tension member being advanced over the guidemembers of FIG. 41;

FIG. 43 is a view of a tension member and leads placed in a leftventricle using the catheter of FIG. 38;

FIG. 44 is a view of a connector for connecting the lead and tensionmember of FIG. 43;

FIG. 45 is a view of the connector of FIG. 44 connecting a lead andtension member;

FIG. 46 is a view of the tension member measuring and tightening device;

FIG. 47 is a cross sectional view of an anchor pad;

FIG. 48 is a cross sectional view of an alternate anchor pad;

FIG. 49 is a perspective view of yet another alternate embodiment of ananchor pad including an anchor pad loosening device;

FIG. 50 is a perspective view of a tension member clip;

FIG. 51 is a cross sectional view of an alternate embodiment of thetension member clip;

FIG. 52 is a cross sectional view of a heart including a tension memberhaving a heat set end;

FIG. 53 is a cross sectional view of a pad including an anchor envelope;

FIG. 54 shows the envelope of FIG. 53;

FIG. 55 is a view of a heart including a external locating device;

FIG. 56 is a perspective view of the external locating device of FIG.55;

FIG. 57 is a cross sectional view of the locating device of FIG. 55including inflated locating balloons;

FIG. 58 is a transverse cross section of FIG. 57;

FIG. 59 is a vertical cross section of the heart including an internallocating device;

FIG. 60 is a cross section of a torso taken through the left and rightventricles including a locating clamp;

FIG. 61 is a view of the locating clamp of FIG. 60;

FIG. 62 is a view of an alternate embodiment of a marking clamp;

FIG. 63 is a cross sectional view of a thread pusher;

FIG. 64 is a cross sectional view of the left ventricle including twothread pushers and a snare;

FIG. 65 is a subsequent view of the devices of FIG. 64;

FIG. 66 is a subsequent view of the device of FIG. 65;

FIG. 67 is a subsequent view of the device of FIG. 66;

FIG. 68 is a cross sectional view of a left ventricle including a snareand thread pusher;

FIG. 69 is a subsequent view of the device of FIG. 68;

FIG. 70 is a cross sectional view of an alternate embodiment of a threadpusher;

FIG. 71 is a cross sectional view of a snare insertion tube;

FIG. 72 is yet another alternate anchor pad embodiment;

FIG. 73 is yet another alternate anchor pad embodiment;

FIG. 74 is yet another alternate anchor pad embodiment;

FIG. 76 is yet another alternate anchor pad embodiment;

FIG. 76 is yet another alternate anchor pad embodiment;

FIG. 77 is a view of an anchor screw;

FIG. 78 is a view of yet another alternate anchor pad embodiment;

FIG. 79 is a view of an anchor epicardial jaw embodiment;

FIG. 80 is vertical cross sectional view of the heart including anchorsdeployed from within the heart; and

FIG. 81 is a vertical cross sectional view of a heart showing tensionmembers deployed from within the heart connected within the heart.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to methods and tools for implanting atransventricular splint. The transventricular splint reduces heart wallstress by changing ventricular geometry. A splint can be full cycle orrestrictive. If a splint is full cycle, it engages, i.e., alters thegenerally globular ventricular shape throughout the cardiac cycle. Ifthe splint is restrictive, it does not change the generally globularshape of the ventricle at end systole.

FIG. 1 is a vertical cross sectional view of a left ventricle view B ofa heart A. A typical transventricular splint 10 is disposed acrossventricle B. Splint 10 includes a tension member 12. Connected toopposite ends of tension member 12 are anchors 14. Anchors 14 engage thewalls of ventricle B to create a shape change either full cycle orrestrictively. FIG. 1A is a horizontal cross sectional view of leftventricle B taken from FIG. 1 showing left ventricle B in a bi-lobeshape as a result of the implantation of splint 10. FIG. 2 is a verticalexterior view of heart A showing splint 10, one end of tension member 12and an anchor 14.

In a preferred method of implanting a transventricular splint, access isgained to the heart. The entry and/or exit points for the splint'stension member are identified. These locations are preferably marked.The tension member is then delivered transventricularly either fromoutside the heart to the inside, or from the inside of the heart to theoutside. The anchors are delivered or deployed. The epicardial length ispreferably measured to calibrate the magnitude of the shape change,tension member length, and thus heart wall stress reduction. Themagnitude of the stress reduction is a function of the tension memberlength. (See U.S. patent application Ser. No. 08/933,456, filed Sep. 18,1997 and incorporated herein by reference.) The heart walls are thendrawn together by adjusting the tension member length and/or anchorspacing. The heart walls are drawn toward each other in view of thedesired tension member length. The anchors are secured to maintain thelength of the tension member. Preferably any portion of the tensionmember not lying between the anchors is removed. The anchors arepreferably secured to the heart to limit relative movement between theanchors and the heart.

Some of the devices and methods disclosed in this application lendthemselves to open chest procedures, whereas others lend themselveseither to open chest procedures or less invasive procedures. Variouscardiac surgical procedures are being done via partial thoracotomybetween ribs. Thoroscopes and trocars are often utilized. Certainembodiments of the invention are amenable to these types of lessinvasive surgery. As is known to one skilled in the art, ports, windowsand trocars are available to access the heart to limit patient traumarelative to open chest procedures. One or more access sites can be usedduring a less invasive procedure to gain access to the heart through thechest wall from a left lateral direction, right lateral direction,anterior and/or posterior direction. For example, during a less invasivesplint implantation procedure, opposite ends of a tension member can beaccessed by left and right lateral ports, where an anterior port is usedto deliver the tension member. During less invasive procedures, thesurgeon's hands preferably remain outside of the patient's body.

When gaining access to the heart by way of a window trocar, both thediaphragm and lungs should be avoided. If the lungs are an obstructionto placement of the trocar and tension member, in some instances theymay be moved without deflation. In yet other instances, if the lungs aresubstantially disposed between the selected chest access point and theheart, the patient may be placed on heart lung bi-pass and the patient'slungs deflated. Ventilation with or without deflation of the lungs maybe desirable.

Once access to the heart through the chest wall has been gained, thesplint placement location should be determined. Determining thedesirable location of the splint is important to the performance andsafety of the device. It is desirable to avoid external structures suchas coronary vessels to avoid negatively effecting the perfusion of bloodthrough the heart wall muscle. It is also desirable to avoid internalstructures such as valve apparatus including chordae. To determine whereto place the splint, the heart can be viewed with the naked eye, echoimaging, echo transesophageally or epicardially and fluoroscopy. Variousdevices can be used to locate entry or exit points by echo imaging orfluoroscopy.

FIG. 3 is a perspective view of a locating device 20 including twoknurled bars 22 interconnected by an elastic member 24. FIG. 4 is a viewof a heart A including a left ventricle B and right ventricle C. Device20 is shown disposed on left ventricle B. Bars 22 can be echo image orviewed by fluoroscopy simultaneously with the left ventricle. Whenviewed by fluoroscopy, coronary vessels can be advantageously visualizedby introducing contrast medium therein. Additionally, bars 22 should bemade from a substantially radiopaque material if used for fluoroscopicimaging.

In use, bars 22 are placed on heart A as shown in FIG. 4. Bars 22 appearto be positioned such that the coronary vessels and internal structureswould be avoided, were the tension member to be extended through theheart between the location of bars 22. The location of the bars can bethe location of the splint tension member. If not, the bars should beshifted into a better location until an acceptable location is found.

In addition to avoiding coronary vessels and internal anatomicalstructures, imaging can be used to determine if the proposed location ofthe splint will produce the desired shape change of the chamber. Thiscould be accomplished with device 20 by pushing knurled bars 22 into theleft ventricle and observing the change in chamber geometry by imaging.

FIG. 5 is a view of a human hand X including a thumb Y and a forefingerZ. An alternate locating device 30 is shown attached to thumb Y andforefinger Z by rings 32. Device 30 also includes a echo visible pad 34.Pads 34 can be used in the same way as knurled bars 22, but rather thanbeing held together by a string 24, pads 34 can be held in place by theuser. FIG. 6 is a view of the surface of pad 34 which would be incontact with heart A during use. Pad 34 preferably includes an echogenicmarker 36 enclosed within a material which has a similar density to theheart wall. The similar density material will reduce echoscatter/reflection versus transmission at the surface and provide easiervisualization of echo marker 36. FIG. 7 is a side view of pad 34 of FIG.6.

FIG. 8 is a side view of a locating device 40. Device 40 can include asyringe 44 having a hypodermic needle 42 in which end 47 preferably doesnot include an exit lumen or orifice. The lumen does, however, extendthrough the remainder of hypodermic needle 42. A balloon envelope isconnected to a portion of hypodermic needle 42 proximate its end 47. Anorifice provides fluid communication between the lumen throughhypodermic needle 42 and inside balloon 46. Balloon 46 can be inflatedwith a echo visible or fluoroscopic visible medium.

FIG. 9 is a view of locating device 40 in which balloon 46 is showninflated within left ventricle B of heart A. By using locator 40 tensionmember entry/exit points can be evaluated in closer proximity tointernal structures than when a locator is placed on the externalsurface of the heart.

FIG. 10 is a vertical cross sectional view of heart A including leftventricle B, right ventricle C and an apex D. A locator device 50 isshown disposed on heart A. Locator device 50 includes apical insertbranch 52 which preferably includes an elongate shaft having aninflation lumen and a tension member delivery lumen extendingtherethrough. The shaft preferably bends transversely near its distalend 54. A balloon 55 similar to the balloon of locator device 40 ofFIGS. 8 and 9 is connected to the distal end of branch 52. Balloon 55can be inflated with a medium visible by echo imagery or fluoroscopy tolocate a tension member entry or exit point on the internal surface ofthe ventricle wall in a manner similar to locating device 40 of FIGS. 8and 9. An optical fiber could be extended through branch 52 and used asdescribed with respect to the device of FIG. 29.

Locator device 50 preferably includes an external branch arm 56connected to branch 52 at connector 59. Branch 56 is bent such that itsdistal end 57 is disposed adjacent distal end 54 of branch arm 52. Anadditional marker 58 is preferably connected to distal end 57 of brancharm 56. Marker 58 is preferably made of material visible either throughecho imaging or fluoroscopy. Branch arm 56 is preferably connected tobranch arm 52 such that as branch arm 52 is rotated, marker 55 andmarker 58 will maintain their relative position to each other, even astheir position changes with respect to left ventricle B.

FIG. 11 is a perspective view of a scissor-like clamp 60 which has ahandle 61 and two clamps ends 62 which are made of a material which isechogenic or by fluoroscopy. Clamp 60 can be opened or closed freely asa pair of scissors or have a locking mechanism to releasably fix thespacing between ends 62. FIG. 12 is a vertical view of a heart A similarto that view of heart A in FIG. 4. Here rather than placing bars 22 onthe heart, ends 62 of clamp 60 are placed on the heart. Ends 62 can beused in a manner similar to bars 22 as described above to locate adesirable positioning of a splint on left ventricle B.

After the tension member entrance/exit points or anchor points on theheart have been identified for the transventricular splint, thelocations can be marked in various ways to assist a surgeon in accurateplacement of a splint when the locator has been removed. Tissue markingpens can be used to mark the location for splint placement.Additionally, sutures can also be placed to provide a marker. Forexample, a purse string suture with or without pledgets could be used toenhance sealing of the tissue around the tension member to reducebleeding as the tension member is advanced through the heart wall.

After marking tension member entry/exit points or anchoring points, anopen chest alignment device, such as alignment device 70 of FIG. 13, canbe placed on the heart to aid in the insertion of the tension memberthrough the chamber from outside of the heart. Alignment device 70includes a handle 71 including holes 72 for the thumb and index fingerof an operator. Alignment device 70 includes two alignment arms havingdistal pad ends 75. Ends 75 include apertures 76 for receiving a tensionmember guide and/or tension member therethrough. Pads 75, arm 74 andhandles 71 are preferably aligned on shaft 77 such that as handle 71 aredrawn toward each other by an operator. Arms 74 and pads 75 will remaingenerally parallel to each other. A spring 78 biases handles 71 apart,and arms 74 and pads 75 together. A locking mechanism can be provided tofix pads 75 in position when a desired spacing has been achieved.Apertures 76 preferably remain axially aligned throughout theoperational spacing of pads 75.

In use, pads 75 are disposed on the heart such that apertures 76 areplaced over the location or markings previously determined for theexit/entry points. Handles 71 are pulled apart until pads 75 are inengagement with the exterior surface of the heart. Alignment device 70is now in position for the next step of the splint placement procedure.

FIG. 14 is an alternate embodiment of an alignment device 80. Alignmentdevice 80 includes handles 81 and an arm 84 and 86 which are pivotableabout a pin 89. Disposed at the end of arm 82 is an alignment pad 83. Analignment pad 85 is rotatably connected by pin 86 to arm 84. A third arm87 is pivotally connected to arm 82 by pin 90 and pivotally connected topad 85 by a pin 88. Pads 83 and 85 each have an aperture 91therethrough. Pads 83 and 85 have heart engaging surfaces 92 which arepreferably parallel to each other within an operational spacing of pads83 and 85. Apertures 91 are preferably axially aligned within thatoperational spacing of pads 83 and 85.

The spacing of pads 83 and 85 can be manipulated by moving handles 81toward each other to increase the spacing of pads 83 and 85 or away fromeach other to decrease the spacing. Pads 83 and 85 preferably engage theheart such that apertures 91 are axially aligned and disposed on thedesired entry/exit point for the tension member. The closer handles 81are moved together, the further pads 83 and 85 move apart.

FIG. 15 is yet an another alternate embodiment of an alignment device100. Alignment device 100 includes handles 101 and elongate arms 102pivotable about pin 104. At the end of elongate arms 102, oppositehandles 101, are alignment pads 103 having orifices 106 extendingtherethrough. A flexible band 105 extends between pads 103.

As described above with respect to the alignment devices of FIGS. 13 and14, the opposite pad orifices should be in axial alignment when placedon the heart. In the case of device 100, this can be accomplished bypivotally mounting pads 103 on arms 102 about a pin 107. FIG. 15A is adetail of a pad 103 pivotally mounted about pin 107 to arm 102. Thearrow in FIG. 15A shows the direction that pad 13 can pivot about point107. It can be appreciated that if opposite pads 103 are mounted asshown in FIG. 15A and if band 105 is sufficiently rigid, band 105 canhold orifices 106 of opposite pads 103 in axial alignment while arms 102are pivoted about pin 104.

Since during the typical implant procedure the heart is still beating,it is preferable to equip the pads of the alignment devices 70, 80 and100 with stabilizing apparatus. The apparatus of FIGS. 16-20 could beincorporated into the pads of alignment devices 70, 80 and 100.

FIG. 16 is a cross sectional view of a pad 111 disposed at an end of analignment device arm 110. The pad is shown in engagement with theexternal wall of left ventricle B. Pad 111 includes an aperture 114extending therethrough for receiving a tension member guide (describedin more detail below) and/or tension member. An annular trough 112 isdisposed around aperture 114. Annular trough 112 is connected to avacuum source line 113 such that a vacuum source can be fluidlyconnected to trough 112. When the vacuum source is applied to trough 112as shown in FIG. 16, a suction force will be created in trough 112drawing pad 111 and the wall of the left ventricle B together.

FIG. 17 is a side view of an alignment device pad 121 disposed at theend of an arm 120 including an alternate stabilization device 122. Anaperture 123 for receiving a tension member guide and/or tension memberextends through pad 121. Stabilization apparatus 122 is preferably aroughened surface disposed on pad 121 to increase the friction betweenpad 121 and the external wall surface of left ventricle B. Apparatus 122could be made from, for example, either the hook or the loop portion ofa hook and loop type fastener.

If a tension member guide or tension member is inserted into the heartusing alignment device 70, 80 or 100, it is preferable that the pad ofthe aperture through the pad at the tension member exit point is oversized in comparison to the pad aperture of the alignment device at thetension member entry point. This is because as the tension member guideor tension member passes through the heart, motion of the heart maycause some minor misalignment of the tension member guide or tensionmember where it exits the heart.

FIG. 18 is a perspective view of a pad 131 disposed on the end of analignment device arm 130. Pad 131 includes an aperture 132 therethrough.This aperture has a diameter preferably between 1.5 and 15 times greaterthan the aperture to the opposite pad. FIG. 18 also shows a notch 133through pad 131 which extends from the exterior of the pad into aperture132. Notch or opening 133 would preferably allow a tension member guideor tension member to be removed transversely from aperture 132 withoutaperture 132 having to moved over an end of the tension member guide ortension member.

FIG. 19 is a perspective view of an alternate embodiment of an alignmentdevice pad 141. Alternate embodiment 141 is disposed at the end of analignment device arm 140. Pad 141 includes a funnel shape aperture 142.Aperture 142 includes a large diameter end 144 and a small diameter end143. Large diameter end 144 is preferably disposed adjacent the heartand tension member exit point during use. A guide tube 145 can lead outfrom smaller diameter end 143 of aperture 142. Guide tube 145 preferablyincludes a bend passing through an arc of preferably between about 45°to about 135° and more preferably about 90°. The radius of the bend ispreferably long enough that devices advanced through guide tube 145 arenot permanently bent as a consequence of being advanced through the arcof guide tube 145. The radius of the are is preferably about 0.05 inchesto about 2 inches, and more preferably between about 0.75 inches and,most preferably about 1 inch as measured to the central axis of guidetube 145.

FIG. 20 is a perspective view of yet another alternate pad embodiment151. Pad 151 has a similar shape to that of FIG. 18 and is disposed atthe end of an alignment device arm 156. Pad 151 has an aperture 152therethrough and a side notch 153 for transverse removal of a tensionmember guide and/or tension member. Extending from arm 156 is a stop arm155 having a tension member guide stop 154 aligned with aperture 156 andspaced from pad 151. In use, stop 154 is disposed on the opposite sideof pad 151 from the heart. As a tension member guide 157 is advancedfrom the heart through aperture 152, advancement of the tip of guide 157is limited by needle stop 154. Stop 154 thus can limit additionaladvancement of guide 157 which might injure tissue adjacent to theheart.

FIG. 21 is a perspective view of an alignment device guide tube 165.Alignment device guide tube 165 preferably includes a luer lock orsimilar coupling 166 releasably connectable to a corresponding coupling161 connected to an alignment device such as 70, 80 or 100 shown above.Coupling 161 of FIG. 21 is shown connected to an alignment branch arm160. The end of the alignment branch arm 160 opposite coupling 161preferably includes a heart engaging pad or surface such as those shownin FIGS. 16 and 17. An aperture 169 extends through coupling 161 in theend of arm 160. A transverse aperture or notch extends into aperture 169such that a tension member guide or tension member can be withdrawn fromaperture 169 transversely without moving aperture 169 over the end ofthe tension member guide or tension member. Guide tube 165 preferablyincludes a funnel shaped guide tube entry port 167 opposite connector166. Guide tube 165 preferably includes a bend passing through an are ofpreferably between about 45° to about 135° or more preferably about 90°.The radius of the bend is preferably long enough that the devicesadvanced through guide tube 165 are not permanently bent as aconsequence of being advanced through the arc of guide tube 165. Theradius of the arc is preferably about 0.25 inches to about 2 inches, andmore preferably between about 0.75 inches to about 1.5 inches and, mostpreferably about 1 inch as measured to the central axis of guide tube165.

In use, aperture 169 is preferably aligned with the desired entry pointfor the tension member. Guide tube 165 can be coupled to coupling 161 ofthe alignment device. If it is difficult to gain access to aperture 169in order to insert the tension member therethrough because coupling 161is directed transversely or posteriorly within the patient's chestcavity, guide tube 165 can be adjusted to dispose guide tube entry port167 generally anteriorly for improved access.

Once alignment device 70, 80 or 100 is in place on the entry/exitpoints, a tension member guide or the tension member can be advancedthrough the alignment device transventricularly through the heart.Preferably, a tension member guide is used to advance the tension membertransventricularly. It is anticipated, however, that if the tensionmember were sufficiently rigid that it could be advancedtransventricularly without a guide.

FIG. 22 is a side view of a tension member guide 170 including a guidetube 176 and stylet 171. Stylet 171 preferably includes a sharpeneddistal end 172 for advancement into and from the heart. The proximal endof stylet 171 can include a luer lock or similar type connector. A tube176 defines an elongate lumen therethrough sized to receive stylet 171or a tension member. Tube 176 preferably includes a luer fitting at itsproximal end 175 opposite its distal end 173.

In use, stylet 171 is advanced through tube 176 as shown by the arrow inFIG. 22. Distal tip 172 of stylet 171 preferably extends distally beyonddistal end 173 of tube 176. Stylet 171 and tube 176 can be coupled byfittings 174 and 175. Then with one of the alignment devices 70, 80 or100 in place, the tension member guide 170, including tube 176 andstylet 171 is advanced either directly through one of the alignmentdevice apertures or by way of a guide tube such as guide tube 165 ofFIG. 21. Tension member guide 170 is then advanced through the oppositeaperture of the alignment device such as shown in, for example, FIG. 20.The length of tube 176 should be long enough to extend through the heartsuch that proximal end 175 and distal end 173 are disposed outside ofthe heart. If the alignment device includes transverse notches or slotssuch as notch 133 of FIG. 18, the alignment device can be removedtransversely from needle 170. Stylet 171 is preferably removed from tube176. The lumen through tube 176 is now unobstructed, providing apassageway for advancing a tension member therethrough.

The primary function of guide 170 and, in particular, tube 176, is toprovide a passageway across the heart. Guide 170 should be flexible andresilient such that guide 170 could be advanced through the bend of, forexample, guide tube 165. Yet, to maintain accurate delivery of guide170, it preferably does not permanently bend when passing through tube165. Column/buckling strength of tension member guide 170 is preferablysufficiently high such that the needle is not deflected as it engagesthe heart wall as guide 170 is advanced from the heart.

Tube 176 is preferably made from Nitinol, polyimide, reinforcedpolyimide or other sufficiently flexible biocompatible material. Tube176 preferably has an inside diameter of about 0.01 inch to about 0.05inch and, more preferably between about 0.02 inches to about 0.03inches. The outside diameter of tube 176 is preferably between about0.015 inches to about 0.07 inches and more preferably between about 0.02inches and about 0.05 inches. Stylet 171 is preferably formed fromNitinol, stainless steel or other sufficiently rigid biocompatiblematerial. Stylet 171 preferably has a diameter of between about 0.005inches and about 0.05 inches and more preferably about 0.26 inches.

FIG. 23 is an alternate embodiment of a tension member guide 180including a stylet 181 having a handle 184 disposed at its proximal endand a sharpened point 182 disposed at its distal end. Stylet 181 isshown extending through a tube 186 having a proximal end 185 and adistal end 183. Guide 180 is essentially similar to guide 170 of FIG. 22except that tube 186 and stylet 181 do not include a coupling mechanism.

FIG. 24 shows a distal end of a stylet 190 similar to stylet 171 of FIG.22. The sharpened tip 191 is shown rounded in comparison to the sharptip 172 of stylet 171 shown in FIG. 22. Tip 191 is rounded such that itcan be advanced through the heart wall without undue pressure or traumayet be deflected from, i.e., not pierce, chordae within the leftventricle which may be encountered as the guide is being advancedtransventricularly. It should be understood that such a tip could beused on stylets of guides 170 or 180 above.

As an alternative to providing a rounded tip for stylets such as tip 191of stylet 90, a retractable sheath 203 can be placed around a stylet 200having a sharpened tip 202. In FIG. 25, sheath 203 is shown in a firstposition retracted away from sharpened tip 202, such that tip 202 isexposed. In FIG. 26, sheath 203 is shown in a second position coveringsharpened tip 202. Sheath 203 and stylet 202 are preferably advancedtransventricularly in a tube similar to tubes 176 or 186 of tensionmember guides 170 and 180. Sheath 203 is preferably spring biased intothe second position shown in FIG. 26 and moved into the first positionas shown in FIG. 25 only as it is advanced through the heart wall. Tobias sheath 203 into the second position, a helical coil spring could beplaced around stylet 200 between a proximal end of sheath 203 and thestylet handle.

FIG. 27 is a view of yet another alternate embodiment 210 of a styletfor a tension member guide. Stylet 210 includes a sharpened tip 211 atthe distal end of a shaft 214 which defines an inflation lumentherethrough. Tip 211 is sealed such that inflation fluid forced throughstylet 214 will exit an orifice 213 disposed within a balloon 212connected to stylet 210 proximate its distal end.

FIG. 28 is a view of stylet 210 of FIG. 27 wherein balloon 212 has beeninflated to cover sharpened tip 211. In use, balloon 212 would beinflated after stylet 214 has been advanced into the left ventricle anddeflated prior to being advanced from the heart and ventricle throughthe heart wall. Stylet 214 preferably is used in conjunction with aguide tube in a manner similar to stylets 171 and 181.

FIG. 29 is yet another alternate embodiment 215 of a tension memberguide 215 in accordance with the present invention. Guide 215 is shownincluding an elongate tube 220 having a distal tip 222 partiallyadvanced through left ventricle B of heart A. FIG. 30 is a view ofdistal tip 222 of guide 215. By reference to FIG. 30, it can be seenthat shaft 222 defines a lumen therethrough in which an optical fiber224 is disposed.

To guide 215 transventricularly, rather than advancing guide 215 throughan alignment device, such as devices 70, 80 or 100, guide 215 isadvanced through a first left ventricular wall where a tension memberentry point has previously been identified. Light is transmitted axiallythrough the lumen within shaft 220 by optical fiber 224. The lightaxially exits distal end 222. If the light is sufficiently bright, itshould be visible from outside of the heart when guide 215 is beingadvanced through the left ventricle. If the visible light is directed ata predetermined exit point, marked on the outside of the heart, needle215 can be advanced through the exit point to outside the heart. Fiberoptic 214 can then be removed from the lumen through shaft 212. Thelumen can then be used as the passageway for advancement of a tensionmember therethrough.

FIG. 31 is an alternate embodiment of a tension member guide 230including an optical fiber 232 disposed around a shaft 231. Shaft 231 isessentially similar shaft 220. Guide 230 can be advancedtransventricularly in a manner similar to that described with respect toguide 215 except that optical fiber 232 need not be removed and shaft231 which defines an elongate lumen extending therethrough.

FIG. 32 is yet another embodiment of a tension member guide 235 having ashaft 236 essentially similar to shaft 220. An optical fiber 237 isdisposed parallel to shaft 236 and connected thereto. In addition to thefiber optic guides of FIGS. 29-32, real time guidance of the tensionmember guide transventricularly can be accomplished by echo imagery orfluoroscopy. The guide in such instances should be echogenic orsubstantially radiopaque.

The fiber optic guides of FIGS. 29-30 lend themselves particularly wellto both open chest and less invasive procedures. When the fiber opticguides are configured for less invasive procedures, the shaft ispreferably advanced through the heart through a lateral port andadvanced out the opposite side of the heart and body through anoppositely disposed lateral port. Opposite ends of the shaft thenpreferably extend outside of the body through the oppositely disposedlateral ports.

FIG. 33 is a perspective view of a scissor like guide clamp 240 whichcan be used to guide a tension member 249 into the tube 248 of a tensionmember guide. Device 240 includes scissor-like handles 241. Handles 241extend to respective arms 242. Each handle 241 and arms 242 form a unitwhich are pivotable about a pin 243. At an end of arms 242 oppositehandles 241, a half conical recess is formed in arm 242. Recess 247leads to a generally semi-circular cross sectional channel 246 which inturn leads distally to a generally semi-circular cross sectional tubereceiving groove at distal end 244 of arm 242.

When arms 242 are brought together as shown in FIG. 34, receivinggrooves 245 form a receiving aperture to receive an end of tensionmember guide 248. Recesses 247 form a tension member receiving openingleading to a tube formed by channels 246. A tension member 249 is shownbeing advanced through tube 248 in the direction of the arrows. Tensionmember 249 could also be advanced from tube 248 through device 240.Channel 246 preferably includes a bend passing through an arc of betweenabout 45° and 135° and more preferably through about 90°.

Once a tension member guide has been delivery transventricularly, and apassageway is created across the chamber, the tension member isdelivered through the passageway. When delivering the tension member,the end of the tension member not being advanced through the passagewaypreferably has an anchor or anchor pad fixably connected thereto. Thiseliminates the need to attach the pad later, but it may not be possiblein the case where the guide includes a hub such as hub 175 of tube 176of FIG. 22. In the case of guide 180 where tube 186 does not include ahub, tube 186 can be withdrawn from the heart over the end of thetension member which was advanced transventricularly. In order to removea tube 176 from a tension member which has been advanced therethroughand has an anchor pad fixably connected to the end of the tension memberwhich was not advanced through tube 176, the tension member should beadvanced through tube 176 beginning at distal end 173 such that the endof the tension member not having the anchor pad emerges from the heartat hub 175. Then tube 176 can be removed over the end of the tensionmember to which a pad has not yet been attached.

Rather than using a tension member guide and/or tension alignment deviceto align the tension member for delivery through the preselected exitand entry points, tubular members 250 such as those shown in FIG. 35 canbe advanced into the left ventricle from oppositely disposedpredetermined entry points on the heart wall to form a splint 253′.Members 250 preferably have ends 250′ which are sufficiently sharp thatmembers 250 can advance through the heart wall without excessivelyinjuring the wall. Members 250 preferably have anchor pads 252′ fixed attheir opposite ends 250′. Members 250 preferably have a lumen definedtherethrough in fluid communication with a lumen defined through pads252′.

After members 250 are advanced into the ventricle through thepredetermined entrance points, a wire hook 253 is advanced from onemember 250 and a wire loop 251 is advanced from the opposite member 250.Hook 253 is then guided into loop 251 either by feel, or by echo imageryor fluoroscopy. Loop 251 preferably has a hook guide 252 to channel hook253 into the member 250 disposed to the left in FIG. 35, as loop 251 isdrawn through that member 250 by pulling ends 251′ of loop 251 to theleft. Loop 251 is preferably drawn through member 250 disposed to theleft in drawing FIG. 35 such that it can be knotted to the left of pad252′ to form a tension member. The knot will restrain hook 253 frombeing pulled back in the heart. The opposite ends 253′ of hook 253 canbe knotted to the right of the pad 252′ disposed to the right in FIG.35. The knot should be sufficiently large to prevent ends 253′ frombeing pulled into ventricle B.

It can be appreciated that members 250 can be placed as shown withoutpads 252′. Loop 251 can be placed across left ventricle B to form atension member as described above. Members 250 can then be withdrawn andpads placed on opposite ends of hook or tension member 253. Alternately,hook 253, once placed across left ventricle B, could be used as atension member lead by fastening a tension member to one end of hook 253and drawing the attached tension member across left ventricle B bywithdrawing hook 253 from the left ventricle B.

FIG. 36 is an alternate embodiment of a splint 260′. A tension member255 is advanced into left ventricle B. An anchor pad 255′ is shownconnected to one end of tension member 255 outside of chamber B. Tensionmember 255 includes a sharpened end 256 which is advanced through themyocardium. Proximate sharpened tip 256 are a plurality ofcircumferential grooves 256. To the left in FIG. 36 is a tension member258′ extending into chamber B. Connected to one end of tension member258′ is a anchor pad 257′. Tension member 258′ includes an outer tube257 and inner receiving tube 258. A loop 259 extends to a side ofreceiving tube 258 and out of the ventricle through a lumen definedbetween tube 257 and 258. Ends 259′ of loop 259 are shown to the left ofpad 257′. An end 261 of tube 258 is preferably thin or sharp enough tobe advanced through heart wall of chamber B.

Tension members 255 and 258′ are advanced into chamber B similarly totension members 250 of splint 253′. Once tension members 258′ and 255have been advanced into chamber B, end 256′ of tension member 255 isadvanced into loop 259. This can be accomplished by feel, or echoimaging or fluoroscopy if loop 259 and tension member 255 are echogenicor radiopaque respectively. After tension member 255 is advanced intoloop 259, loop 259 is drawn to the left by pulling ends 259′ to theleft. Tension member loop guide 260 engages with a groove 265 andtension member 255 and end 256′ are drawn into receiving tube 258 tounite tension members 258′ and 255. Ends 259′ are then tied to preventloop 259 from shifting to the right in FIG. 37.

It can be appreciated that members 255 and 258′ can be advanced intoleft ventricle B while not having pads 255′ and 257′ attached thereto,respectively. Once members 255 and 258′ are placed across left ventricleB and connected as shown in FIG. 37 they can be used as a tension memberguide tube such as guide tube 176 of FIG. 22.

FIG. 38 is a vertical cross sectional view of left ventricle B of heartA including apex D showing an alternate device for placing a tensionmember. A catheter 265 having an elongate shaft 265′ is disposed in partwithin ventricle B. Shaft 265′ has a distal end 266 and a transversebend proximate end 266. Shaft 265′ has a proximal end 267. An elongatelumen is defined through shaft 265′ between proximal end 267 and distalend 266. Shaft 265′ is sufficiently rigid that distal end 266 can beadvanced through apex D. A purse string suture is preferably placed onapex D aground shaft 265′ to control bleeding. Catheter 265 is advancedinto ventricle B such that distal tip 266 is brought into contact withthe ventricular wall at a location where the tension member will exitchamber B. Catheter 265 preferably include a retractable brace wire 268′having a distal end fixably connected to shaft 265 proximate thetransverse bend. Brace wire 268′ extends proximally outside of shaft265′ to an orifice where it enters shaft 265. Wire 268′ then extendswithin shaft 265′ proximal to the proximal end of shaft 265′. Whenadvancing catheter 265 into ventricle B, wire 268′ can be pulledproximally drawing wire 268′ parallel and adjacent to shaft 265′. Oncecatheter 265 is disposed within ventricle B, wire 268′ can be shifteddistally to bow transversely and brace catheter 265 against aventricular wall opposite distal end 266.

Distal tip 266 preferably includes a radiopaque marker such as thatshown in FIG. 10, so that tip 266 can be viewed by fluoroscopy or anecho marker for echo visualization. The radiopaque or echo marker can beused to locate the tension member exit points. Once a tension memberexit point is determined, a tension member 268 can be advanced throughthe lumen of catheter 265. The tension member should be sufficientlyrigid and have a distal end sufficiently narrow or sharpened that it canbe advanced through the ventricular wall. After tension member 268 ispassed through the ventricular wall, catheter 265 is removed fromventricle B and wire 268. Catheter 265 is then reinserted into leftventricle B through apex D along side tension member 268.

The location of a second tension member exit point is determined, thistime rather than advancing a tension member through the lumen ofcatheter 265, a hypotube 269 having a distal tip 270 and shown in FIG.39, is advanced through catheter 265. Distal tip 270 passes through theheart wall at the location of the second tension member exit point. Tube269 need not be a hypotube but could be another tube having sufficientpushability to be advanced through the heart wall at the second tensionmember exit point. Distal tip 270 should be narrow enough orsufficiently sharpened to traverse the heart wall. A proximal end ofhypotube 268 should remain outside the heart and proximal apex D. InFIG. 39, catheter 265 has been removed proximally from hypotube 269 asit was from tension member 268. After hypotube 269 has been placed asshown in FIG. 39, the proximal end of tension member 268 is advancedinto proximal end 271 of hypotube 269. The proximal end of tensionmember 268 is advanced through hypotube 269 until it exits chamber B byway of the distal end 270 of hypotube 269.

In FIG. 40, tension member 268 is shown extending from distal end 270 ofhypotube 269. Hypotube 269 is shown being withdrawn in the direction ofthe arrow over tension member 268. After hypotube 269 is withdrawn, thetension member 268 is then in place across ventricle B It canappreciated that tension member 268 has been placed without an alignmentdevice such as alignment devices 70, 80 or 100. Anchors or anchor padscan be placed on the tension member on opposite sides of the heart andadjusted as described in more detail below. The remainder of the stepsnecessary to complete the placement of the transventricular splint willbe discussed in detail below.

FIG. 41 is a vertical cross section of left ventricle B of heart Aincluding apex D showing an alternate method of placing a tensionmember. Two guide members 270 and 271 are shown advanced through apex Dand out opposite sides of chamber B. Guide members 270 and 271 have beenplaced in this position in a manner similar to the way that tensionmember 268 was placed as shown in FIG. 39.

FIG. 42 is a view of a tension member 272 including guide tubes 273disposed at each of its ends. Guide tubes 273 have distal ends 274 whichmust be sufficiently narrow or sharpened to penetrate the ventricularwalls. Guide tubes 273 as shown, have been advanced through apex D overguide members 270 and 271. Tension member 272 must be sufficiently rigidto provide sufficient pushability to advance guide tubes 273 throughapex D over guidewires 270 and 271 and through the ventricular walls.Once guide tubes 273 have been advanced through oppositely disposedventricular walls, tension member 272 can be pulled taunt acrossventricle B. Once tension member 272 is drawn across ventricle B,anchors can be disposed on tension member 272 on opposite sides of heartA as described in more detail below.

FIG. 43 is a vertical cross section of left ventricle B of heart Aincluding apex D. As shown in FIG. 43, leads 275 and 276 have beenadvanced through apex D and opposite ventricular walls in a mannersimilar to guidewires 270 and 271 as shown in FIG. 41. Connected toleads 275 and 276 by connectors 278 is a tension member 277. Thisarrangement may be used in a situation wherein tension member 277 issubstantially less pushable or rigid than leads 275 and 276. Leads 275and 276 must first be placed in a manner similar to guide members 270and 271 of FIG. 41, such that the ends of leads 275 and 276 extendthrough the side walls of ventricle B and apex D. Then the relativelyflexible tension member can be drawn into ventricle B. As shown in FIG.43, tension member 277 is partially drawn into ventricle B. Ultimatelyleads 275 and 276 are drawn in opposite directions until tension member277 extends transventricularly across ventricle B and passes through theventricular wall to the exterior of heart A. Once tension member 277 isdisposed on opposite sides of the heart, anchors or pads can be attachedto opposite ends of the tension member to form the transventricularsplint. The splint can be adjusted as described in more detail below.

FIG. 44 is a view of connector 278 of FIG. 43. Lead 275 includes a loop280 disposed at one end. Tension member 277 includes a hook 279 disposedat one end. A locking tube 281 is slidably disposed over a portion ofhook 279. To complete the connection between lead 275 and tension member277, hook 279 is hooked to loop 280. Hook 279 is then collapsed suchthat hook lock 281 can be slid over the collapsed portion of hook 279 toretain loop 280 in place on hook 279 as shown in FIG. 45.

The tools and methods shown and described with respect to FIGS. 38-43lend themselves both to open chest and less invasive implantationprocedures. They are particularly suited to less invasive procedureswhere the apex of the heart is accessed through an anterior port and theventricular walls are accessed through oppositely disposed lateral portssuch that opposite ends of the tension member can extend into oppositelydisposed lateral ports. Rather than gaining access through the apex,those tools shown in FIG. 38-43 gaining access the left ventriclethrough the apex could instead access to the left ventricle through theaortic valve or mitral valve. Access through the aortic valve ispreferably obtained through the aorta by way of either a carotid orfemoral artery access point. Access to the mitral valve can be obtainedby way of a port, window or the like and may be a particularly desirableroute if mitral valve replacement or repair is done in conjunction withsplint implantation.

With respect to those tension members placed ventricularly throughtension member guides as described above, it was indicated that it ispreferable to connect an anchor or anchor pad to the end of the tensionmember not being advanced through the guide tube prior to advancing thetension member through the guide tube. It is not necessary to connectthe pad to the tension member at that time, however. In the case ofthose embodiments where the tension member is advanced into theventricle from opposite sides as shown in FIGS. 35-37, it is preferablethat the anchors or anchor pads are connected to the tension membersprior to advancement of the tension members into the ventricle. Hereagain, having the anchors connected to the tension members at this timeis not required, however. With respect to those methods and tools shownin FIGS. 38-43, the pads are preferably placed on opposite ends of thetension member after the tension member is disposed transventricularlyand both ends of the tension member are exposed outside of the heart.

Once the pads or anchors are disposed on the tension member, the lengthof the tension member disposed between the pads is preferably adjusted.This adjustment is preferably made by fixing the position of one of thepads on the tension member and allowing the other pad to slide along thetension member. With respect to the splints of FIGS. 35-37, however,both pads can be affixed to the respective tension members prior toadjusting the overall length of the splint (by placement of the knots asdescribed above). The pad which is fixed to the tension member is drawninto engagement with the external wall of the heart by pulling on theend of the tension member opposite the fixed pad. Then the other pad isbrought into engagement with the external wall of the heart by slidingit along the tension member toward the pad which is fixed on the tensionmember. The pads can be placed on opposite ends of the tension member byway of left lateral and right lateral ports to perform thetransventricular splint implant less invasively.

The effective length of the tension member, i.e., the distance betweenthe pads measured along the tension member, can be correlated with themagnitude of heart wall stress reduction. For an idealized calculationof this relationship, please see U.S. patent application Ser. No.08/933,456, filed Sep. 18, 1997, and incorporated herein by reference.It is also anticipated that the force exerted axially along the tensionmember by the heart engaging the pads can also be correlated with heartwall stress reduction.

FIG. 46 is a view of a measuring device 300 through which a tensionmember 302 has been threaded. One end of tension member 302 extendsthrough left ventricle B of heart A. An anchor pad 304 has been fixedlyattached to tension member 302 and end 303 and drawn into engagementwith heart A. The second pad 306 has been placed on tension member 302but has not been tightened, i.e., fixedly attached to tension member302. Pad 306 is free to slide along tension member 302. Extending fromanchor pad 306 is a tether or string 308. In general, it may bedesirable to attach a tether to the anchor pads as shown herein. Thiswould make them easier to retrieve if they were dropped within the chestcavity during a splint implantation procedure.

Measuring device 300 includes an elongate tension member receiving tube310 having a distal end including a pad engagement member 312 and aproximal end 316 connected to a preferably clear measuring tube 314having a measuring scale 315 marked thereon. Tension member 302 has beenthreaded through tube 310 and tube 314. Tension member 302 has also beenthreaded through a tube 318 having a retaining block 319 and a screw 320at one end tightened to releasably hold tension member 302. Screw 320 ispreferably connected to a force transducer. Another block 322 isdisposed at the opposite end of tube 318. A screw 326 extends into block322 to releasably hold guidewire 302. Block 322 is disposed adjacentblock 324 connected to tube 314. Interconnecting block 322 and 324 is aguide rail 330 and adjustment screw 328. Adjustment screw 328 can berotated to move screw and block 320, tube 318, block 322, screw 326 andthus, tension member 302 through tube 314.

Tension member 302 preferably has a visible index mark 332 placed alongits length a known distance from end 303 of tension member 302.Measuring tube 314 preferably magnifies mark 332. The length of tube 310and pad engaging member 312 as well as tube 314 should also be known andcorrelated to scales 315 such that by determining the location of mark332 relative to scale 315, the length of tension member disposed betweenpads 304 and 306 can be determined. Set screw 328 can be adjusted untilthe desired length of tension member 302 between pads 304 and 306 isachieved. Then pad 306 can be fixed in place along tension member 302.Tether 308 is preferably removed. It can be appreciated that tube 310can be sufficiently long to be advanced through a port for adjusting thelength of tension member 302 less invasively.

The distance between pads 304 and 306 is preferably related to theradius R₁ of the unsplinted left ventricle. For purposes of thisexplanation, 2R₁ can be viewed as the length of the tension memberbetween pads 34 and 36 at end diastole where the pads are spaced suchthat no shape change is induced by the splint. When pads 306 and 304 arefixed along tension member 302 the distance along the tension memberbetween the pads can be considered l. It can be appreciated that if lwere greater than 2R₁ no shape change to the left ventricle would beinduced throughout the cardiac cycle. At the opposite extreme, l couldbe so short that the opposite walls of the left ventricle are held orpressed together between pads 304 and 306 throughout the cardiac cycle.Preferably, however, the ratio l/2R₁ is preferably between about 0.4 toabout 0.8 and more preferably between about 0.5 to about 0.7 and mostpreferably about 0.6.

In addition to measuring the length of tension member 302 between pads304 and 306 to determine their desired spacing, it is anticipated thatdevice 300 can be used to measure axial force on the tension member aspad 306 is engaged against heart A and advanced toward 304 along tensionmember 302. To accomplish this, in the preferred embodiment, the device300 also includes a force transducer 334 and pin vice 336. Pin vice 336can be tightened to fixably hold tension member 302. If screws 320 and326 are loosened such that only pin vice 336 retains tension member 302from sliding distally within the device 300, the distally directed forcein tension 302 will be transferred by pin vice 336 to force transducer334. The axial force detected by the transducer can be observed bycalibrating the transducer or connecting it to a monitor in a mannerknown to those skilled in the art of force transducers. Set screw 328can be adjusted until the desired force is obtained. The surface of thepad itself could also be centered to create pores for tissue ingrowth.When the desired force level is achieved, pad 306 could be fixed inplace along tension member 302.

With respect to any of the transventricular splints disclosed herein,the length of the tension member can be adjusted to form a full cyclesplint or restrictive splint. If the length of the tension member issuch that the anchors or anchor pads engage the heart to create a shapechange throughout the cardiac cycle, the splint created is a full cyclesplint. If the anchor or anchor pads do not engage at end systole tocreate a shape change, the splint formed is a restrictive splint.

FIG. 47 is a cross sectional view of an embodiment of anchor pad 340 inaccordance with the present invention. Anchor pad 340 preferablyincludes a disc shaped pad portion 342. Disc shape pad portion 342includes side 343, which in use is disposed toward the heart. A conicalaperture 348 having sloping sides 346 extends through pad 342. Collet344 is disposed within orifice 348. A threaded portion 350 of collet 344extends from orifice 348 opposite side 343, nut 352 is threaded overthreaded portion 350. Lumen 345 extends through collet 344. A tensionmember 354 is shown extending through lumen 345. Lumen 345 has adiameter such that when nut 352 is not tightened on threaded portion350, tension member 354 can slide freely through lumen 345. When nut 352is tightened, it draws collet 344 away from side 343. Collet 344 is thenpinched between walls 346 of orifice 348. When collet 344 is pinched,the size of lumen 345 is reduced such that tension member 354 can nolonger move freely within lumen 345, fixing the position of pad 340 ontension member 354.

FIG. 48 is a cross sectional view of an alternate embodiment an anchorpad 360 in accordance with the present invention. Anchor pad 360includes a generally disc-shaped pad portion 362. Pad 362 includes aside 363 which when the pad is in use, is disposed toward the heart. Atension member lumen 364 extends through pad 362. Lumen 364 preferablyhas a generally conical shaped portion 365 disposed toward side 363.Tension member 370 is shown disposed through lumen 364 in FIG. 48. Pad362 includes a threaded passage 366 extending from an edge of pad 362 tolumen 364. A set screw 368 is threaded into passage 366. Set screw 368can be tightened to engage tension member 370 to fix the position ofanchor pad 360. When set screw 368 is not tightened, the size of lumen364 is preferably large enough that anchor pad 360 can slide relativelyfreely over tension member 370.

FIG. 49 is a perspective view of yet another embodiment of anchor pad380 in accordance with the present invention. Anchor pad 380 preferablyincludes a generally disc-shaped pad portion 382 having a first side 383which in use would be disposed toward the heart and a second side 385.Pad 382 as well as pads 342 and 362 are preferably formed from a metalsuch as stainless steel alloys or titanium alloys.

A tension member fastener 384 is formed in pad 382 by cutting a seriesof grooves and apertures through pad 382 from side 385 to side 383. Afirst groove 386 has a generally horseshoe shape. Second groove 388extends between opposite portions of horseshoe shaped groove 386 to formtwo oppositely disposed cantilever members 387. A relatively largeaperture 394 is formed between cantilever members 387 proximate theirfree ends. A second and smaller aperture 390 is formed closer to thefixed ends of cantilever members 387. Tension member 392 is shownextending through aperture 390.

As shown in FIG. 49, tension member 392 is clamped between cantilevermembers 387 such that the location of pad 382 is fixed along tensionmember 392. Pad 382 can be released by using a spreading device 396 tospread cantilever members 387 apart. Spreading device 396 includeshandle 398 to spreading arms 400 each having a finger 402. Fingers 402can be placed within aperture 394 then arms 400 and fingers 402 can bespread apart by pivoting them around a pin 404 such that cantilevers 387are spread apart and pad 382 can move freely along tension member 392.It can be appreciated that although spreader 396 is shown extendingtransversely from tension member 392, it could also be configured suchthat fingers 402 do not curve transversely from arms 400 and thusspreader 396 could be disposed parallel to tension member 392. Thiswould be particularly desirable in a situation where anchor pad 380 wasbeing placed through a port or window during a less invasive splintimplantation procedure. It can be appreciated that cantilever members387 can be held apart such that pad 380 can be moved along tensionmember 392 by placement of a temporary wedge or pin in groove 388. Forexample, grooves 388. may include an additional small aperture disposedbetween aperture 390 and aperture 394 into which a pin could be placedto hold open members 387. When it is desired to fix the position ofanchor pad 380 on tension member 392, device 396 could be used to spreadcantilever members 387 to remove the pin. The cantilever members couldthen be released to engage tension member 392. Aperture 390 of pad 380can also include a conical portion disposed toward side 383 such asconical portion 365 of pad 360.

Cantilever arms 384 are preferably configured such that they do notstress tension member 392 beyond its elastic limit. It can also beappreciated that the force developed by cantilever members 387 impingingon tension member 392 is operator independent and defined by thegeometry and material characteristics of members 387.

FIG. 50 is a perspective view of an anchor pad 360 having a tensionmember 370 extending therethrough. After pad 360 is secured to tensionmember 370, that portion of tension member 370 which extends from theside of anchor pad 360 opposite side 363 is preferably removed. This canbe accomplished by trimming tension member 370 with wire cutter 414 orscissors. Although anchor pad 360 is used here to illustrate trimmingtension member 370, it can be appreciated that in each of theembodiments disclosed herein there may be an excess portion of tensionmember extending from an anchor, which is preferably removed or trimmed.

FIG. 51 is a cross sectional view of an alternate embodiment 420 of atension member cutter. Device 420 includes an elongate outer tube 422having a distal end 424. Tube 424 defines a lumen 423 through whichextends a second tube 430 having a distal end 428. Extending distallyfrom distal end 428 are two cutting arms 424 and 426 which are shownpartially withdrawn into lumen 423 and transversely restrained by distalend 424 of outer tube 422. When unrestrained by distal end 424, arms 424and 426 are biased apart. Each arm 424 and 426 has a cutting element 425and 427, respectively. Elements 425 and 427 are shown in contact witheach other in FIG. 51. A tension member 370 extends between arms 424 andthrough lumen 432 of inner tube 430. A representative anchor pad 360 isdisposed adjacent elements 425 and 427. Device 420 of FIG. 51 isparticularly useful when trimming excess tension member using lessinvasive techniques as it can be readily advanced over a tension memberthrough a port or window.

FIG. 52 is a vertical cross sectional view of left ventricle B of heartA. A transventricular splint 443 including a tension member 370 andanchor pads 360 are shown disposed on heart A. To the left of heart A asshown in the figure is a coiled portion 442 of tension member 470. As analternative to trimming an excess length of tension member, tensionmember 370 could be formed from a shape memory alloy such that portion442 could be preset to assume a coil shape when warmed to near bodytemperature.

Once the length of the tension member has been adjusted, the anchors aresecured in place along the tension member and the excess length oftension member removed if desired, the anchor or anchor pads arepreferably secured in place on the heart. The anchor or anchor pads aresecured such that relatively movement between the anchors or anchor padsand the heart is limited to reduce abrasion of the heart wall. To securethe anchor or anchor pads to heart A, a biocompatible adhesive could beplaced between the pad and the heart to adhere the pad to the heart.Alternately, apertures could be provided in the pad such that suturescould be extended through the apertures and into the heart to secure thepad. In addition to sutures, the pad could include threaded aperturesinto which anchor screws could be advanced through the pad and into theheart wall to secure the pad to the heart.

FIG. 53 illustrates yet another alternative approach to securing theanchors or anchor pads to the heart surface. FIG. 53 is a crosssectional view of an anchor pad 340 disposed on heart A. Anchor pad 340is disposed within an envelope 446. Envelope 446 includes a bottom layer447 disposed between anchor pad 340 and heart A and a top layer 448disposed on the opposite side of anchor pad 340. Layers 347 and 340 areheld together by sutures 449. Bottom layer 447 is preferably a meshdacron or expanded PTFE which has a pore size or intranodial dimensionsufficient to promote tissue ingrowth. The pore size is preferablybetween about 10 and about 100 microns and more preferably, betweenabout 20 and about 40 microns. With respect to expanded PTFE, theintranodial dimension is preferably between about 10 to about 100microns and more preferably between about 20 to about 40 microns. Thetop material could also be dacron or expanded PTFE or the like having apore size which preferably does not promote ingrowth and thus resistsadhesion to surrounding tissue.

Envelope 446 would preferably be placed around pad 340 prior to placingpad 340 on tension member 354. A window 450 can be provided to provideaccess to nut 352 to secure pads to tension member 354. After tighteningnut 352, window 450 can be closed by suture 452. FIG. 54 is a top viewof pad 340 and envelope 446 of FIG. 53. It can be appreciated that asimilar envelope can be placed around the various anchor pads disclosedherein. The location of the window may have to vary, however, to provideaccess to the respective means for securing the anchor pads to thetension member.

FIG. 55 shows an alternate embodiment of a splint locating device 460disposed on heart A. It can be appreciated, however, that alternatelocating device such as that shown in FIGS. 13-15 could also be used.Heart A includes left ventricle B, right ventricle C and apex D. Splintlocating device 460 which is particularly useful in performing lessinvasive procedures. Device 460 can be advanced through an anterior portor window to apex D and onto heart A as shown in FIG. 55. Device 460includes an elongate catheter shaft 462 having a lumen extendingtherethrough. Extended from the distal end of catheter shaft 462, aretwo arms 464 preferably biased to spread apart from each other whenadvanced distally from catheter shaft 462. Connected to the distal endof wires 464 is a band 466. Band 466 preferably readily elongates, i.e.,increases in diameter as it is advanced onto heart A, such that band 466does not substantially alter the pumping performance of heart A.

FIG. 56 is a view of the device 460 disposed on heart A. Wires 464 areshown extending from catheter shaft 462 distally to band 466 andproximally from catheter shaft 462. Prior to advancing catheter 460through a port or window to apex D, wires 464 are preferably pulledproximally into shaft 462. Band 466 can also be folded and pulled intoshaft 462 or folded and disposed parallel to shaft 462 for advancementthrough the port or window. Once the distal end of shaft 462 is advancedto apex D of heart A, wires 464 can be shifted distally to deploy band466 and the adjacent portions of wires 464 in heart A.

FIG. 57 is a generally vertical cross sectional view of left ventricle Bof heart A including apex D. Catheter 460 is shown deployed on heart A.Band 466 has been advanced sufficiently high on heart A such that theadjacent portions of wires 464 will lie proximate potential entry/exitpoints for the tension member guide or tension member. As can be seen inFIG. 57, two balloon catheters 468 have been advanced over wires 464.Those skilled in the art will recognize that catheters 468 could beconfigured similarly to an over-the-wire or rapid exchange angioplastycatheter. Balloon catheters 468 include a distally disposed balloon 469which would be larger than angioplasty balloons, however.

FIG. 58 is a transverse cross sectional view of chamber B and catheter460 taken from FIG. 57. Balloons 469 have been inflated to induce ashape change in chamber B similar to that shown in FIG. 1A. Balloons 469can be inflated with a radiopaque or echogenic inflation fluid such thatthey can be visualized by fluoroscope or echo imagery. If the balloonsare imaged in this way, a portion 469′ of each balloon 469 engages heartA can be considered as a location for the exit/entry points for thetension member. The criteria for evaluating the location is similar tothat described above with respect to the locators of FIGS. 3-12 above.Device 460 can also be used acutely as a temporary splint.

FIG. 59 is a vertical cross sectional view of left ventricle B of heartA having an apex D on which another alternate embodiment 470 of alocator device is shown disposed within chamber B. Locator device 470includes an elongate catheter shaft 472 having a distal end 478.Extending from distal end 478 is a wire or elastic ribbon 476. Wire 476is shown extending transversely from distal end 478 to radiopaque orechogenic markers 479. Additional wires or leads 474 extend proximallyfrom markers 479 to a ring or hub 475 disposed outside of heart A. Toadvance catheter 470 into chamber B or withdraw it therefrom, hub 475 ispulled distally along shaft 472 to draw wires 474, markers 479 and wires476 generally parallel to and adjacent shaft 472. In this position,catheter 470 can be advanced through or withdrawn from chamber B by wayof a port or window used for less invasive procedures. Catheter 470 andmarkers 479 can be used to locate the entry/exit points similarly to thelocators shown in FIGS. 4-12 and in particular, the marker 55 of FIG.10.

FIG. 60 is a transverse cross section of a human torso through heart A,left ventricle B and right ventricle C, right lung E and left lung F.Locator 60 of FIG. 11 is shown being advanced less invasively to heartA. FIG. 61 is a same human torso cross section as shown in FIG. 60,except that locator 60 has been brought into engagement with heart A asshown from a different perspective in FIG. 12. FIG. 62 is yet anotherview of the same torso cross section where a locator 485 havingscissor-like handle 486 and arms 488 are coupled by an elongate linkage487. As can be appreciated by those skilled in art, arms 488 can bedrawn together or spread apart by an operating handle 486. The distalend of arms 488 should be echogenic or radiopaque such that they can beviewed by echo imaging or fluoroscopy similarly to end 62 of locator 60.Locator 485 is shown advanced to heart A through a lateral leftapproach. Locator 485 is preferably advanced through a port not shown ofa type known to those skilled in the art. It can be appreciated thatlocator 485 can be used to locate a splint at a different location thanlocator 60.

An alternate method of splint placement could advantageously use athread pusher and snare. FIG. 63 is a view of a thread pusher 500.Thread pusher 500 includes a housing 502 defining a lumen 503therethrough. Extending from lumen 503 is a shaft 504 having a sharpeneddistal tip 506. Shaft 504 defines a lumen 507 in fluid communicationwith lumen 503 of housing 502. Shown disposed within lumen 503 andadvancable into lumen 507 is a plunger 508. Plunger 508 has a distal end510. Plunger 508 defines an elongate lumen 511 extending the length ofplunger 508. Disposed through lumens 503, 511 and 507 is a thread 512.Lumen 511 preferably has a diameter just slightly greater than thediameter of thread 512. Lumen 507, however, has a diameter great enoughto coil a substantial length of thread 512 therein. The necessary lengthof thread 512 can be appreciated in view of the discussion which followsregarding the use of thread pusher 500.

FIG. 64 is a generally vertical cross sectional view of left ventricle Bof heart A having apex D, aortic valve G and mitral valve H. Disposedwithin chamber B is a catheter 520 having an elongate catheter shaft 522extending through apex D of heart A to proximate aortic valve G. A wireor line 526 extends through an elongate lumen through shaft 522, loopsto form a snare 524 at the distal end of shaft 522 and returns backthrough the lumen. As shown in FIG. 64, snare 524 is disposed generallyaround or preferably through the orifice of aortic valve G. Two threadpushers have been advanced from opposite sides of heart A such thatdistal tips 506 of shafts 504 are disposed within chamber B. Plunger 508of thread pusher 500 has been advanced to release previously coiledportion 514 of thread 512 into chamber B. As shown by the arrows, bloodflow leaving chamber B exits through aortic valve G. As shown in FIG.64, this blood flow has carried threads 512 through snare 524 and aorticvalve G.

FIG. 65 shows the same cross sectional view of left ventricle B as FIG.64, except that snare 524 has been partially retracted by pulling line526 proximally. Catheter 520 has also been partially withdrawn in aproximal direction from chamber B. FIG. 66 is yet another view of thecross section of left ventricle B as shown in FIG. 64, except that snare524 has been withdrawn proximally from catheter 522 such that an end ofeach thread 512 is disposed proximally of shaft 522.

FIG. 67 is yet another view of the cross section of left ventricle Bshown in FIG. 64, except that threads 512 have been joined and extendacross left ventricle B. To achieve the configuration of FIG. 67, theends of threads 512 disposed proximally of shaft 522 in FIG. 66 are tiedtogether. Then the opposite ends of thread 522 are pulled proximallyrelative to respective thread pushers 500 until threads 512 arewithdrawn from catheter shaft 522 and extend across chamber B. Threadpushers 500 can be withdrawn proximally from threads 512. Joined threads512 can be used as a tension member to assemble a transventricularsplint. Preferably, however, after thread pushers 500 are removed fromthreads 512, a tension member is connected to one of the free ends ofthread 512 by, for example, tying the end of thread 512 to a loop formedin an end of a tension member. Then the remaining free end of thread 512can be withdrawn proximally until both threads 512 are pulled fromchamber B and the tension member extends across the chamber. Once thetension member extends across the chamber, the remainder of the splintcan be assembled in a manner similar to that contemplated for thetension members placed in accordance with FIGS. 38-43.

It can be appreciated that the method of placing a tension memberdescribed with respect to FIG. 64 can advantageously be performed by anopen chest or less invasive route. The method described, however, lendsitself particularly well to a less invasive approach where oppositelydisposed lateral ports are used to manipulate string pushers 500 and ananterior port is used to access apex D by catheter 520. As analternative to the apical approach, snare 524 could be placed from anaortic or mitral valve approach. If the approach is by way of the aorticvalve, the snare may be advanced thereto by way of the aorta from acarotid or femoral artery access point. The mitral valve approach couldbe made by way of a port or window. The mitral valve port may beparticularly desirable if mitral valve repair or replacement ispreformed in conjunction with splint implantation.

FIGS. 68 and 69 illustrate yet another method of placing a tensionmember across ventricle B using snare 524, and a thread pusher 500.Unlike the method described with respect to FIGS. 64-67, the lateralapproaches are preferably used without requiring access to apex D.Catheter 520 is advanced from one side of chamber B and placed generallyaround distal tip 506 of shaft 504 of thread pusher 500 which isadvanced into chamber B from the opposite side. Plunger 508 is depressedto push the coiled portion of thread 512 into chamber B. Thread 512drifts toward aortic valve G and through snare 524 under the influenceof blood flow.

As shown in FIG. 69, snare 524 is tightened around thread 512 andwithdrawn from chamber B. It can be appreciated that catheter 520 andthread pusher 512 can be removed from thread 512 and a splint assembledin the manner described above with respect to the tension member placedin accordance with the method described in FIGS. 64-67. It can also beappreciated that this method can advantageously be applied to implant asplint either by an open chest or less invasively using two oppositelydisposed lateral ports.

FIG. 70 is a longitudinal cross sectional view of an alternateembodiment of a thread pusher 610. Thread pusher 610 includes a threadinsertion shaft 612 having a lumen 612 extending therethrough. Shaft 612can have a curved distal end 614 which preferably includes a sharpenedportion 618 for insertion through the heart wall into the leftventricle. A handle 620 is preferably disposed at the proximal end ofshaft 612. A plunger 622 is preferably disposed within shaft lumen 616.Plunger 622 includes a distal end 626 and a proximal end preferablyincluding a handle 628. A lumen 624 extends through plunger 622. Athread or filament 611 is shown disposed within shaft lumen 616 andplunger lumen 624. Unlike thread pusher 500 of FIG. 63, the length ofshaft 612 is preferably long enough that the portion of thread 611 to beadvanced into the left ventricle can be disposed within lumen 616without being coiled.

In use, distal tip 618 of thread pusher 610 is disposed in leftventricle B in a manner similar to that of tip 506 of thread pusher 500.Plunger 622 is then advanced into shaft lumen 616 to advance thread 611into the left ventricle. Thread 612 is preferably lightly frictionwithin lumen 624 or held within lumen 624 by the user or holding cap629.

FIG. 71 is a generally vertical cross section of left ventricle Bshowing a longitudinal cross sectional of a snare insertion tube 630disposed through apex D. Insertion tube 630 preferably includes anelongate shaft 632 having an elongate lumen extending therethrough. Anannular flange 638 is preferably disposed at the proximal end of shaft632. Disposed in engagement with, and distally of flange 638 is anannular felt pad 636. A stylet 640 having an elongate shaft 642 and ahub 644 can be inserted within the lumen of shaft 632.

In use, snare insertion tube 630 can be used to provide a stable accessthrough apex D for catheter 520 when performing the procedure shown inFIGS. 64-67 above. Insertion tube 630 can be advanced into apex D asshown. As insertion tube 630 is advanced into apex D, stylet 640 ispreferably disposed therein to limit bleeding through the lumen throughshaft 632. Felt pad 636 is preferably sutured to apex D to limitbleeding around shaft 632 and stabilize insertion tube 630 on apex D.Stylet 640 is then removed and then catheter 520 can be advanced throughinsertion tube 630 to perform the splint implantation.

Up to this point, it has been assumed that access was obtained orobtainable to each end of the tension member for placement of an anchoror anchor pad thereon. Access to each end of the tension member placedacross the left ventricle is generally obtainable by open chest accessor lateral, anterior or posterior ports. It is contemplated, however,that under some circumstances, however, it may be difficult orundesirable to obtain access to one or both ends of the tension member.Under such circumstances, it may be desirable to be able to deliver ananchor or anchor pad to a wall of the ventricle to which direct accessby open chest or port has not been obtained. In such an instance, it maybe desirable to deliver the anchor or anchor pad from inside the heartto the outside.

FIG. 72 is a cross sectional view of a portion of left ventricle Bincluding a distal portion of a tension member 532 having a balloonanchor 536 disposed at its distal end and outside of chamber B of heartA. Tension member 532 is preferably a tubular member such as a hypotubesealed at its distal end except for an orifice 534 disposed withinballoon 536. The distal end of tension member 532 including balloon 536can be advantageously and preferably advanced to the position shown byusing any of the methods and devices disclosed above which advance thetension member from inside the heart to outside, for example, the methodand device described above with respect to FIGS. 38-40. Once the distalend of tension member 532 is advanced to the position shown, balloon 536can be inflated from a collapsed position to the expanded positionshown. Balloon 536 is preferably expanded using quick cure polymer suchas cyanoacrylate or mixed two-part epoxy or other biocompatiblesubstance which will allow balloon 536 to remain in an expanded positionchronically. Saline is preferably used as inflation fluid if the balloonis inflated acutely.

FIG. 73 is a similar view to that of FIG. 72 except a tension member 542having a pad 544 is shown disposed in left ventricle B. Pad 544 ispreferably a coiled pad which can be delivered as described above withrespect to the balloon of FIG. 72, except that it may be preferable toadvance pad 544 through the heart wall through a tube. Coil 544 can becompressed within the tube and upon emerging from the tube and theheart, expand Coil 544 could also could be formed from a shape memoryalloy and be preset to expand at approximately body temperature.

FIG. 74 is yet another example of an anchor pad deployable from insidethe heart to outside the heart. Pad 554 is shown disposed at the end ofthe tension member 552. Pad 554 includes two arms pivotally connected totension member 522 by hinge 556. Hinge 556 preferably allows arms 555 torotate from a first position parallel and adjacent to tension member552, to a second position approximately perpendicular to tension member552 as shown. To deploy pad 554, pad 554 is advanced from the heartthrough the heart wall with arms 555 disposed in the first positionuntil the arms are completely advanced to the outside of the wall. Thentension member 552 is drawn in the opposite direction such that the endsof arms 555 engage the heart wall and pivot into the second position astension member 552 continues to be pulled.

FIG. 75 is yet another embodiment of an anchor pad 565 which can beplaced from inside the heart to outside by the methods applicable to thedevice of FIG. 72. Pad 565 includes two arms 564 hingably connected totension member 562. Arms 564 include a hinge 566. Pad 565 can beadvanced through the heart wall while arms 564 are parallel and adjacentto each other. Once arms 564 have been advanced to the outside of theheart, a wire or line 568 connected to the distal end of arms 566 andextending proximally through tension member 562 can be pulledproximately to shorten the distance between the ends of arms 564 andbend arms 564 outward at hinges 566.

FIG. 76 is yet another embodiment of an anchor pad 574 disposed on adistal end of tension member 572. Pad 574 has an umbrella-like shape,the top of the umbrella being disposed away from the heart wall and thebroad base of the umbrella being disposed toward the heart wall. Pad 574is advanced through the heart wall in a collapsed position. Pad 574 canbe biased to expand upon passing through the heart wall or can beexpanded in a manner similar to pad 554 of FIG. 74.

FIG. 77 is a view of anchor or anchor screw 584 disposed at the distalend of a tension member 582. Screw 584 unlike the anchor pads of FIGS.72-76 does not have to pass through the heart wall to secure tensionmember 582 in place. Rather, anchor 584 has a corkscrew or auger shape.Screw 584 is anchored to the myocardium by rotating tension member 582while advancing anchor 584 into the myocardium.

FIG. 78 is a view of yet another embodiment of anchor pad 612 disposedon an end of a tension member 610. Pad 612 is preferably a fabric suchas dacron or PTFE. A fast acting adhesive can secure pad 612 to theheart wall as shown. The adhesive can be, for example, cyanoacrylate.The adhesive can be triggered by reaction with the heart wall tissue, bepressure sensor, be activated by an accelerator or energy source.

FIG. 79 is a cross section of a portion of left ventricle B similar tothat shown in FIG. 72-78 except that the epicardium I is shown. Thedevice of FIG. 79 includes a tubular tension member 592 including ananchor or an epicardial jaw anchor 594 disposed at its distal end. Jawanchor 594 is connected to a wire or line disposed through the lumen oftension member 592. The jaw anchor 594 is biased to open whenunrestrained by the distal end of tension member 592. If wire 596 ispulled proximally, jaws 594 will engage the distal end of tension member592 tending to close anchor jaws 594, by a mechanism similar to that ofthe device of FIG. 51, except that anchor jaws 594 are not intended tocut but rather grip.

It should be noted that not only can the anchors and anchor pads ofFIGS. 72-79 be advantageously employed when one of the ends of thetension member extending outside the heart will not be directlyaccessible to deploy a pad thereon, but also where neither end of thetension member will be accessible to place a pad thereon. In such aninstance, two tension members having anchors or anchor pads as shown inFIGS. 72-79 can be placed through an apical approach similarly to howguide members 270 and 271 were placed in FIG. 41. Once the anchors oranchor pads are deployed, however, the two tension members arepreferably connected to form effectively a single tension member.

FIG. 80 is a vertical cross sectional view of the left ventricle B ofheart A having apex D. For purposes of illustrating the deployment oftwo tension members and anchors or anchor pads without direct access tothe distal ends of the tension members, outside the heart, for placementof the pads thereon, two tension members 532 having balloons 536disposed at their distal ends are shown placed on left ventricle B. Itcan be appreciated that tension members 532 and balloons 536 can beplaced on the heart in a manner similar to guide members 270 and 271 ofFIG. 41. Then catheter tube 600 can be advanced over tension members532. Tension members 532 can then be drawn proximally to reduce thedistance between pads 536 to create either a full cycle or restrictivesplint.

FIG. 81 is the same cross sectional view as FIG. 80 except that catheter600 has been removed from chamber B and a tension member fastener 602has been placed to interconnect tension members 532. Fastener 602 can beformed from a disc similar to pad 382 of FIG. 49, but form with anadditional tension member receiving aperture 390. To place fastener 602,fastener 602 can be advanced through catheter 600 over tension members532 by an elongate spreader. The spreader can be removed and fastener602 clamped to tension members 532. Then the catheter 600 can be removedto obtain the configuration shown in FIG. 80. It should also be notedthat prior to removing catheter 600, tension member cutter 420 of FIG. 1could be advanced over the tension members to remove the excess lengthshown extending through apex D.

It can be appreciated that the method of FIGS. 80 and 81 can beperformed open chest or less invasively. When performed less invasively,an anterior access port is preferably used. In addition to performingthe methods of FIGS. 80 and 81 by way of apex D, access could be gainedto left ventricle B by way of the aortic valve or mitral valve asdescribed above.

The effective length of the tension member between anchor pads 536 canbe determined by knowing the overall length of each tension member andthe length of catheter 600. The effective length of the tension memberwill be the sum of the lengths of the tension members less two times thelength of catheter 600 and less the length of each tension memberextending proximally from catheter 600 when the distal end of catheter600 abuts fastener 602. If pads 536 were made from echogenic orradiopaque material the effective length of the tension could beestimated by echo imaging or fluoroscopic techniques. It can also beappreciated that the length of the tension member can be measureddirectly be advancing a measuring device into chamber B.

Numerous characteristics and advantages of the invention covered by thisdocument have been set forth in the foregoing description. It will beunderstood, however, that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size and ordering of steps without exceeding the scope of theinvention. The invention's scope is, of course, defined in the languagein which the appended claims are expressed.

1. A system for treating a heart, comprising: a delivery catheter; meansfor penetrating the walls of a heart chamber; a device for treating theheart by applying tension across a heart chamber to reduce the lateraldistance between two walls of the chamber; and means for temporarilysecuring the delivery catheter in place within a heart chamber while thedevice for treating the heart is placed in a heart chamber.
 2. Thesystem of claim 1, wherein the delivery catheter has a selectivelyformable distal section that can be formed into at least two curvedportions.
 3. The system of claim 2, wherein the shape of one of the atleast two curved portions is complementary to the interior shape of achamber of a heart such that the delivery catheter can be braced againstthe walls of a heart chamber on opposite sides of the chamber.
 4. Thesystem of claim 2, wherein the directional orientation of the distalsection of the delivery catheter can be changed by manipulating at leastone catheter control member.
 5. The system of claim 1 wherein the meansfor penetrating the walls of a heart chamber is a puncture catheter. 6.The system of claim 1, wherein the device for treating the heartcomprises: an elongated tension member; a distal anchor member attachedto a distal end of the tension member; a proximal anchor member; andmeans for securing the tension member such that it is fixedly attachedto the proximal anchor member.
 7. The system of claim 6, wherein theanchors are made from a material selected from a group consisting of anickel-titanium alloy, stainless steel, a biocompatible shape-memorymaterial, a biocompatible superelastic material, and a combinationthereof.
 8. The system of claim 6, wherein at least one of the anchormembers further comprises a plurality of flexible struts.
 9. The systemof claim 1, wherein the means for temporarily securing the deliverycatheter in place within a heart chamber is a temporary anchor.
 10. Thesystem of claim 9, wherein the delivery catheter has an anchor lumen andthe temporary anchor is an elongated section of wire.
 11. The system ofclaim 10, wherein a distal end of the anchor can be extended from thedelivery catheter adjacent the wall of a heart chamber and the anchorcan assume a shape that temporarily stabilizes the delivery catheter inthe heart chamber until the anchor is withdrawn into the deliverycatheter.
 12. The system of claim 1, wherein at least a portion of thedevice for treating the heart includes a therapeutic agent selected froma group consisting of an antithrombotic, an anticoagulant, ananti-inflammatory, and a combination thereof.
 13. A system for treatinga heart, comprising: a delivery catheter having a selectively formabledistal section that can be formed into at least two curved portions; apuncture device; a device for treating the heart having an elongatedtension member, a distal anchor member attached to a distal end of thetension member; a proximal anchor member, and means for securing thetension member such that it is fixedly attached to the proximal anchormember; and at least one temporary anchor for temporarily securing thedelivery catheter in place within a heart chamber.
 14. The system ofclaim 13, wherein the shape of one of the at least two curved portionsis complementary to the interior shape of a chamber of a heart such thatthe delivery catheter can be braced against the walls of a heart chamberon opposite sides of the chamber.
 15. The system of claim 13, wherein atleast one of the anchor members further comprises a plurality offlexible struts.
 16. The system of claim 13, wherein at least a portionof the device for treating the heart includes a therapeutic agentselected from a group consisting of an antithrombotic, an anticoagulant,an anti-inflammatory, and a combination thereof.